Medline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A, which contains Meridian Nexus Unilimb Rebreathing Circuit, part 40301-1-30, among other components needed for open heart surgery; Made in USA by Medline Industries, Inc., Mundelein, IL 60060
This recall has been terminated (originally issued April 27, 2005).
- Company
- Medline Industries, Inc.
- Recall Initiated
- March 18, 2005
- Posted
- April 27, 2005
- Terminated
- October 17, 2005
- Recall Number
- Z-0769-05
- Quantity
- 116 kits
- Firm Location
- Waukegan, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The procedure packs contain anesthesia/breathing circuits being recalled by MMS Sales due to partial occlusion of the T-piece resulting in airway obstruction.
Distribution
California, Alabama, Minnesota, Florida and Indiana.
Lot / Code Info
reorder number CDS840144A, lots 04JD2847, 04LD2995, 05AD3946, 05BD0929, 05BD4100
Root Cause
Other
Action Taken
Recalled from the direct account hospitals via letter dated 3/18/05 and 3/23/05. The letters informed the accounts of the occlusion via copy of the MMS recall letter, and listed the Medline reorder number and lot numbers of the custom packs shipped to them, along with the MMS part number contained there in. The accounts were requested to examine their stocks for the affected codes and return them to Medline.